EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The Eu­ro­pean Med­i­cines Agency on Fri­day re­ject­ed Ky­owa Kirin’s Parkin­son’s dis­ease drug Nouryant (istrade­fylline), which the US FDA ap­proved in 2019 un­der the brand name Nouri­anz.

EMA said it con­sid­ered that the re­sults of the clin­i­cal stud­ies used to sup­port the ap­pli­ca­tion “were in­con­sis­tent and did not sat­is­fac­to­ri­ly show that Nouryant was ef­fec­tive at re­duc­ing the ‘off’ time. On­ly four out of the eight stud­ies showed a re­duc­tion in ‘off’ time, and the ef­fect did not in­crease with an in­creased dose of Nouryant.”

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